Therapeutic oral device for sleep apnea

ABSTRACT

The present disclosure provides generally for a therapeutic oral device for sleep apnea and associated methods for using the device. According to the present disclosure, the device may comprise a hard palate portion, mouth guard portion, and a tongue retainer portion. The hard palate portion may comprise one or more materials. The hard palate portion may also comprise a composite of materials, including but not limited to embedded materials. The mouth guard portion may comprise one or more components that provide stability and maintain the position of the therapeutic oral device within the mouth. The tongue retainer portion may comprise an airway and a predetermined length. A method of use may comprise the utilization of one or more incremental oral devices to overcome a gag reflex. When the oral device is formed from a mold, the mouth guard portion and the hard palate portion may be custom fit to the dimensions of the intended mouth.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to and the full benefit of U.S.Provisional Patent Application Ser. No. 63/139,051 (filed Jan. 19, 2021,and titled “THERAPEUTIC ORAL DEVICE FOR SLEEP APNEA”), the entirecontents of which are incorporated in this application by reference.

BACKGROUND

Sleep apnea is a sleeping disorder in which the sleeper's breathing isstopped repeatedly throughout the night. The disorder may cause snoring,restless sleep, difficulty falling asleep or insomnia, excessivesleepiness throughout the day, and more. A number of factors may causeor exacerbate sleep apnea, such as being obese, having a large neckcircumference or narrow air passageways, being male, aging, usingsedatives, alcohol, or narcotics, and smoking.

There are three types of sleep apnea: obstructive, central, and complex.Obstructive sleep apnea is the most common type and occurs when thethroat muscles relax, narrowing the passageway for air to enter orleave. This lack of oxygen flow alerts the brain and wakes up thesleeper, so that breathing may continue as normal. Although the wakeoften goes unnoticed by the sleeper because it is so brief, this adds tothe restlessness and sleepiness symptoms of the sleeper. Central sleepapnea occurs when the brain fails to transmit signals to the breathingmuscles. So rather than a physical obstruction preventing someone frombreathing, the sleeper simply makes no effort to breathe and may awakenwith shortness of breath. Complex sleep apnea is a combination ofobstructive and central.

In addition to the many symptoms of sleep apnea, there may also be longterm complications that arise as a result of the disorder. Extremefatigue may occur, and may not only consist of drowsiness, but may alsoaffect being able to concentrate, which may affect work performance,increase the risk of workplace or motor vehicle accidents, or causedrastic mood changes. Due to the sudden drops in oxygen levels, theheart may have to work harder than normal, which may increase the chanceof high blood pressure, stroke, heart attacks, and more. Those withsleep apnea have an increased risk of developing type 2 diabetes.Additionally, sleep apnea may cause complications with standardmedications or medical procedures, including surgeries.

Many treatments, devices, and even surgeries have been developed overthe years to remedy sleep apnea, though each comes with its unique prosand cons. One of the most commonly used devices is the continuouspositive airways pressure (CPAP). The CPAP machine requires the sleeperto wear a mask over his nose and mouth, which delivers air at a greaterpressure than the surrounding air. This higher air pressure helps theairways stay open, preventing sleep apnea. CPAP machines, however, maybe uncomfortable for the wearer, cause claustrophobia or anxiety, andincrease the likelihood of dry mouth, nose bleeds, and nasal congestion.CPAP machines cost anywhere from $500-3000, require a prescription, andmay not be covered by health insurance.

Other treatments may include wearing an oral appliance, such as amouthguard or orthodontic retainer, which places pressure on the tongue,nerve stimulation, which sends precise stimuli to nerves in the airway,and nutrition or exercise therapies. Surgery may also work in someinstances. This treatment type is most effective for children who getlarge adenoids or tonsils removed. For adults, it may be difficult topinpoint what exactly is causing the sleep apnea. Some adult surgicalprocedures may consist of removing tissue throughuvulopalatopharyngoplasty, shrinking tissue with radiofrequencyablation, repositioning the jaw, or implanting rods. Although theseprocedures may be successful for some, the CPAP machine is still therecommended method of treatment by most physicians.

SUMMARY OF THE DISCLOSURE

What is needed is a convenient and comfortable way to treat sleep apneathat is accessible, budget-friendly, and does not cause other healthissues. A mechanical, removeable oral appliance removes electricalrequirements and increases design simplicity. An oral appliance thatmimics the basic form of a mouth guard possesses a familiarity throughassociation that enables the user to quickly discern its functionality.The compact nature of an oral appliance that resembles a mouth guardallows for transportability and compact storage. The removeable aspectof the oral appliance avoids issues of prolonged wear such as tissuenecrosis and inflammation.

The present disclosure provides generally for a therapeutic oral devicefor sleep apnea. According to the present disclosure, the device maycomprise a hard palate portion, mouth guard portion, and a tongueretainer portion. In some embodiments, the hard palate portion maycomprise one or more materials. In some implementations, the hard palateportion may also comprise a composite of materials, including but notlimited to embedded materials. In some aspects, the mouth guard portionmay comprise one or more components that provide stability and maintainthe position of the therapeutic oral device within the mouth. In someembodiments, the tongue retainer portion may comprise an airway and apredetermined length. In some implementations, the method may compriseone or more incremental oral devices to overcome a gag reflex. When theoral device is formed from a mold, the mouth guard portion and the hardpalate portion may be custom fit to the dimensions of the intendedmouth.

The present disclosure relates to a therapeutic oral appliance that mayinclude a mouth guard portion, where the mouth guard portion may beconfigured to at least partially interface with one or more teeth of auser; a hard palate portion configured to at least partially interfacewith a hard palate of a mouth of the user, where the hard palate portionextends upward from the mouth guard portion; a tongue retainer portion,where the tongue retainer portion extends from the hard palate portioninto at least a portion of a throat of the user, where the tongueretainer portion may comprise an upper surface, a lower surface, and alongitudinal length; and an airway, where the airway may comprise one ormore recesses within at least one of the upper surface of the tongueretainer portion and the lower surface of the tongue retainer portion,where the airway extends along at least a portion of the longitudinallength of the tongue retainer portion.

In some embodiments, the mouth guard portion may comprise at least onesafety mechanism. In some implementations, the tongue retainer portionmay be fixed to a distal end of the hard palate portion. In someaspects, the longitudinal length of the tongue retainer portion may beadjustable. In some embodiments, the mouth guard portion may comprise atleast one external attachment configured to interface with at least onesupplemental device. In some implementations, the at least one externalattachment may comprise at least one aperture.

In some aspects, the at least one supplemental device may comprise atube. In some embodiments, the mouth guard portion may comprise auniversal fit that may be used by a generic user. In someimplementations, the therapeutic oral appliance may be configured tointerface with at least one wearable device. In some aspects, the atleast one wearable device may comprise a smart watch. In someembodiments, the mouth guard portion may be configured to interface withone or more dental fixtures. In some implementations, the one or moredental fixtures may comprise braces.

In some aspects, the therapeutic oral appliance further may comprise oneor more sensors. In some embodiments, the one or more sensors maycomprise at least one of an accelerometer, a heart rate monitor, a pulseoximeter, and a capnograph. In some implementations, the therapeuticoral appliance may be configured to interface with at least one externaldevice. In some aspects, the at least one external device may compriseat one of a smartphone, a desktop computer, a laptop computer, a tablet,and a medical apparatus. In some embodiments, the mouth guard portionmay comprise at least one wire. In some implementations, the mouth guardportion may comprise an at least partially customized fit for a specificuser. In some aspects, the mouth guard portion may be adjustable. Insome embodiments, the hard palate portion extends upward from the mouthguard portion to a point of central convergence.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings that are incorporated in and constitute a partof this specification illustrate several embodiments of the disclosureand, together with the description, serve to explain the principles ofthe disclosure:

FIG. 1A illustrates a top-down view of an exemplary therapeutic oralappliance, according to some embodiments of the present disclosure.

FIG. 1B illustrates a side view of an exemplary therapeutic oralappliance, according to some embodiments of the present disclosure.

FIG. 1C illustrates a perspective view of an exemplary therapeutic oralappliance, according to some embodiments of the present disclosure.

FIG. 2A illustrates an exemplary therapeutic oral appliance, accordingto some embodiments of the present disclosure.

FIG. 2B illustrates a cross-sectional view of an oral cavity with anexemplary therapeutic oral appliance, according to some embodiments ofthe present disclosure.

FIG. 3A illustrates an exemplary therapeutic oral appliance comprising atongue retainer portion, according to some embodiments of the presentdisclosure.

FIG. 3B illustrates an exemplary cross-sectional view of an oral cavitywith an exemplary therapeutic oral appliance, according to someembodiments of the present disclosure.

FIG. 4A illustrates an exemplary therapeutic oral appliance comprising atongue retainer portion, according to some embodiments of the presentdisclosure.

FIG. 4B illustrates an exemplary a cross-sectional view of an oralcavity with an exemplary therapeutic oral appliance, according to someembodiments of the present disclosure.

FIG. 5A illustrates an exemplary therapeutic oral appliance comprising atongue retainer portion, according to some embodiments of the presentdisclosure.

FIG. 5B illustrates an exemplary a cross-sectional view of an oralcavity with an exemplary therapeutic oral appliance, according to someembodiments of the present disclosure.

FIG. 6A illustrates an exemplary therapeutic oral appliance comprising atongue retainer portion, according to some embodiments of the presentdisclosure.

FIG. 6B illustrates an exemplary a cross-sectional view of an oralcavity with an exemplary therapeutic oral appliance, according to someembodiments of the present disclosure.

FIG. 7A illustrates an exemplary therapeutic oral appliance comprising atongue retainer portion, according to some embodiments of the presentdisclosure.

FIG. 7B illustrates an exemplary cross-sectional view of an oral cavitywith an exemplary therapeutic oral appliance, according to someembodiments of the present disclosure.

FIG. 8A illustrates a front view of an exemplary therapeutic oralappliance, according to some embodiments of the present disclosure.

FIG. 8B illustrates a rear view of an exemplary therapeutic oralappliance, according to some embodiments of the present disclosure.

FIG. 9 illustrates a mouth wearing an exemplary therapeutic oralappliance, according to some embodiments of the present disclosure.

FIG. 10 illustrates an exemplary therapeutic oral appliance with asafety mechanism, according to some embodiments of the presentdisclosure.

FIG. 11A illustrates a side view of an exemplary therapeutic oralappliance with a mouth guard portion attachment, according to someembodiments of the present disclosure.

FIG. 11B illustrates a perspective view of an exemplary therapeutic oralappliance with a mouth guard portion attachment, according to someembodiments of the present disclosure.

FIG. 12A illustrates a side view of an exemplary therapeutic oralappliance interfacing with an external device, according to someembodiments of the present disclosure.

FIG. 12B illustrates a side view of an exemplary therapeutic oralappliance interfacing with an external device, according to someembodiments of the present disclosure.

FIG. 12C illustrates a perspective view of an exemplary therapeutic oralappliance interfacing with an external device, according to someembodiments of the present disclosure.

FIG. 13A illustrates a side view of an exemplary therapeutic oralappliance with a mouth guard portion attachment, according to someembodiments of the present disclosure.

FIG. 13B illustrates a perspective view of an exemplary therapeutic oralappliance with a mouth guard portion attachment, according to someembodiments of the present disclosure.

FIG. 14A illustrates a side view of an exemplary therapeutic oralappliance with a mouth guard portion attachment, according to someembodiments of the present disclosure.

FIG. 14B illustrates a perspective view of an exemplary therapeutic oralappliance with a mouth guard portion attachment, according to someembodiments of the present disclosure.

FIG. 15A illustrates a side view of an exemplary therapeutic oralappliance with an adjustable tongue retainer portion, according to someembodiments of the present disclosure.

FIG. 15B illustrates a top-down view of an exemplary therapeutic oralappliance with an adjustable tongue retainer portion, according to someembodiments of the present disclosure.

FIG. 16A illustrates a side view of an exemplary therapeutic oralappliance with an adjustable tongue retainer portion, according to someembodiments of the present disclosure.

FIG. 16B illustrates a top-down view of an exemplary therapeutic oralappliance with an adjustable tongue retainer portion, according to someembodiments of the present disclosure.

FIG. 17 illustrates an exemplary therapeutic oral appliance, accordingto some embodiments of the present disclosure.

FIG. 18 illustrates an exemplary therapeutic oral appliance, accordingto some embodiments of the present disclosure.

FIG. 19 illustrates an exemplary adjustable therapeutic oral appliance,according to some embodiments of the present disclosure.

FIG. 20 illustrates an exemplary therapeutic oral appliance attachableto dental fixtures, according to some embodiments of the presentdisclosure.

FIG. 21 illustrates an exemplary therapeutic oral appliance withwireless data transmission capabilities, according to some embodimentsof the present disclosure.

FIG. 22A illustrates a process of forming an exemplary therapeutic oralappliance, according to some embodiments of the present disclosure.

FIG. 22B illustrates a process of forming an exemplary therapeutic oralappliance, according to some embodiments of the present disclosure.

FIG. 23 illustrates a process of forming an exemplary therapeutic oralappliance, according to some embodiments of the present disclosure.

DETAILED DESCRIPTION

In the following sections, detailed descriptions of examples and methodsof the disclosure will be given. The description of both preferred andalternative examples, though thorough, are exemplary only, and it isunderstood to those skilled in the art that variations, modifications,and alterations may be apparent. It is therefore to be understood thatthe examples do not limit the broadness of the aspects of the underlyingdisclosure as defined by the claims.

Glossary

-   -   Therapeutic oral appliance: as used herein refers to a device        inserted into the mouth that assists in maintaining an        unobstructed airway for therapeutic purposes. In some aspects, a        therapeutic oral appliance may limit risks associated with sleep        apnea by limiting movement of the tongue.    -   Tongue retainer portion: as used herein refers to a portion of        the therapeutic oral appliance that limits backward movement of        the tongue when the therapeutic oral appliance is worn. In some        embodiments, a tongue retainer portion may comprise airways that        may prevent occlusion of the throat, allowing for unobstructed        breathing.    -   Hard palate portion: as used herein refers to a portion of the        therapeutic oral appliance that is configured to at least        partially interface with the hard palate within the mouth of a        user.    -   Mouth guard portion: as used herein refers to a portion that        fits to or over at least a portion of one or more teeth. In some        aspects, a mouth guard portion may be customized to fit a user's        teeth, such as through use of a dental mold. A mouth guard        portion may comprise an at least partially customized fit for a        specific user. In some embodiments, a mouth guard portion may        have a more universal fit that may be used by a generic user        without requiring a custom fitting.    -   OSA: as used herein refers to obstructive sleep apnea.

Referring now to FIGS. 1A-1C, an exemplary therapeutic oral appliance100 is illustrated. In some embodiments, the therapeutic oral appliance100 may comprise a tongue retainer portion 110. In some implementations,the tongue retainer portion 110 may comprise one or more predeterminedlengths. This may allow the user to gradually become accustomed to thepresence of the tongue retainer portion 110 within at least a portion ofthe throat. Gradual introduction may allow for the suppression of thegag reflex, which may occur as the length of the tongue retainer portion110 enters the throat. In some aspects, the tongue retainer portion 110may comprise an upper surface, a lower surface, and a longitudinallength.

In some embodiments, the therapeutic oral appliance 100 may be utilizedto relieve airway obstruction from a one or more sources. As anillustrative example, the therapeutic oral appliance 100 may directlyrelieve obstruction caused by obstruction at the back or base of thetongue, uvula, and soft palate. The therapeutic oral appliance 100 maypartially relieve obstruction that is caused by issues below theepiglottis such as hypopharyngeal issues, vocal cord folds andarytenoids, anterior-posterior soft palate collapse, lateral soft palatecollapse, complete concentric collapse, epiglottic and tonsillarcollapse. The therapeutic oral appliance 100 may address a plurality ofissues of obstruction simultaneously through prescribed therapeutic use.

In some implementations, the therapeutic oral appliance 100 maycontribute to partial relief of obstruction by improving overall muscletone of the oropharynx. This improvement may result as muscles resistand gain tone by resisting the therapeutic oral appliance 100. In someaspects, an airway 115 may provide airflow from the mouth to the softpalate. This may improve breathing and decrease airway obstruction.

In some embodiments, the material of the therapeutic oral appliance 100may comprise materials that are sufficiently durable and chemicalresistant to sanitize the therapeutic oral appliance 100 on a dailybasis by chemical (e.g., mouth wash or alcohols) means or physical means(e.g., steam sterilization), as non-limiting examples. In someimplementations, the removeable aspect of the therapeutic oral appliance100 may allow the user to clean and sanitize the therapeutic oralappliance 100 frequently. This may facilitate accessible cleaning thatmay reduce the possibility of tissue necrosis and infection, as anon-limiting list.

In some implementations, the therapeutic oral appliance 100 may comprisea hard palate portion 130. In some embodiments, the mating connected bysymmetric surfaces between the hard palate and the hard palate portion130 may improve the stability of the therapeutic oral appliance 100within the oral cavity. In some aspects, the therapeutic oral appliance100 may comprise a mouth guard portion 120. In some additional aspects,the hard palate portion 130 may extend upward from the mouth guardportion 120 to a central point of convergence.

In some embodiments, the mouth guard portion 120 may comprise acomposite of materials. This may prevent fracture and fragment wear thatcould cause worn parts of the therapeutic oral appliance 100 to beswallowed. In some implementations, the substrate material may beembedded within the primary material.

As an example, a hard plastic plate may be embedded in the medium ofethylene-vinyl acetate (EVA), or an elastomeric polymer, as the softerplastic cures within the teeth mold. In some aspects, the embeddedsubstrate may be fragmentary. As another example, an EVA material mayhave plates of harder plastic embedded in the regions over the rearmolars to reduce wear from teeth grinding. In some embodiments, thetherapeutic oral appliance 100 may comprise a coated aspect. As anexample, the therapeutic oral appliance 100 may be coated in a hardenedplastic film that reduces torsional fatigue within the structure of thetherapeutic oral appliance 100.

The mouth guard portion 120 may be configured to at least partiallyinterface with one or more teeth of a user. This interface may maintainthe position of the therapeutic oral appliance 100 in the mouth andprevent ingestion of the therapeutic oral appliance 100. In someaspects, the therapeutic oral appliance 100 may comprise a hard palateportion 130. The hard palate portion 130 may interface with the hardpalate within the mouth. In some implementations, the mouth guardportion 120 and the hard palate portion 130 may reduce point pressure byspreading the retaining force for the therapeutic oral appliance 100across a larger surface area.

The mouth guard portion 120 may provide protection to the soft sensitivetissue of the oral pharynx. A mouth guard portion 120 may protect theparts of the hard palate, soft palate, and oral pharynx from pressurepoints, as a non-limiting list. The pressure may originate from the oralairway. The mouth guard portion 120 may prevent pain and possible tissuenecrosis by preventing these pressure points. In some aspects, the mouthguard portion 120 may extend to cover the hard and soft palate toprotect sensitive tissues. This protection may assist in pushing theoral airway away from the oropharynx. In some embodiments, moving theoral airway away from the oropharynx may decrease the gag reflex.

In some implementations, the level of customization of the therapeuticoral appliance 100 may vary. As an illustrative example, a user mayreceive a dental impression in a dentist's office that provides ahigh-fidelity model of the unique aspects of the user's mouth. Thisimpression may be formed via physical or digital dental impression. Thisimpression may become the casting for the therapeutic oral appliance100. This high level of customization may allow the fit of thetherapeutic oral appliance 100 to match the form of the hard palate andteeth with precision. It may also improve the overall comfort andperformance of the oral device. The oral device can be customized to fiteach user's unique dentition, maxillary or dental arch, palatal arch orvault, and palatal mucosa and rugae, thus making the least intrusiveoral airway size and path for maximal comfort.

As another illustrative example, a user may purchase a therapeutic oralappliance 100 remotely. The therapeutic oral appliance 100 may bedelivered as a generic casting of a therapeutic oral appliance 100. Thegeneric mold may fit most mouths in a loose composition. The genericcasting may then become pliable after boiling it in water. Thispliability may allow the user to press the therapeutic oral appliance100 firmly into their mouth to allow the therapeutic oral appliance 100to harden in the shape of the user's mouth. This formed fit may providesufficient stability, without requiring a dentist visit.

In some embodiments, the therapeutic oral appliance 100 may interfacewith the oral cavity. The quality of the interface may contribute tosafety, comfort, and effectiveness as a therapeutic device, as anon-limiting list. In some implementations, the removeable aspect of thetherapeutic oral appliance 100 may also provide opportunity for frequentsanitation. This may prevent infection, inflammation, and tissuenecrosis, as non-limiting examples.

In some embodiments, the mouth guard portion 120 may interface with theteeth. This interface may maintain the position of the therapeutic oralappliance 100 in the mouth and prevent ingestion of the therapeutic oralappliance 100. In some aspects, the therapeutic oral appliance 100 maycomprise a hard palate portion 130. The mouth guard portion 120 and thehard palate portion 130 may reduce the probability of subconsciousrejection of the therapeutic oral appliance 100 by spitting it out. Thecustom fit of the therapeutic oral appliance 100 may reduce thisprobability by increasing comfort. In some aspects, the interfacebetween the therapeutic oral appliance 100 and the oral cavity mayassist in alignment of the tongue retainer portion 110 within thethroat. Unsecured movement of the tongue retainer portion 110 may resultin triggering the gag reflex or choking.

In some embodiments, the tongue retainer portion 110 may be fixed to andextend from a distal end of the hard palate portion 130 into at least aportion of the throat sufficient to reduce movement of the tongue. Insome implementations, the tongue retainer portion 110 may be trimmablefor preferential comfort and fit within the throat, as non-limitingexamples. In some aspects, the tongue retainer portion 110 may preventthe tongue from falling back and touching the soft palate, which mayotherwise create airway obstruction. In some embodiments, the tongueretainer portion 110 may comprise an airway 115 that ensures airflowwhen the tongue retainer portion 110 occupies the throat.

In some aspects, the tongue retainer portion 110 may comprise an airway115. In some implementations, the airway 115 may comprise one or morerecesses or slots within the upper and/or lower surface of the tongueretainer portion 110 that extend along at least a portion of thelongitudinal length of the tongue retainer portion 110, thereby formingone or more channels or grooves. In some embodiments, airway 115channels may provide an airway to allow air flow. In someimplementations, the airway 115 may follow the natural anatomical airwaypassage of the user. This may decrease the chance of inadvertent airwayobstruction by the therapeutic oral appliance 100. The conformity to thenatural anatomy of the oral cavity may result from the custom fit of thetherapeutic oral appliance 100.

Referring now to FIG. 2A, an exemplary therapeutic oral appliance 200 isillustrated. Referring now to FIG. 2B, a cross-sectional view of an oralcavity with an exemplary therapeutic oral appliance 200 is illustrated.In some embodiments, the therapeutic oral appliance 200 may comprise ahard palate portion 230. In some implementations, the therapeutic oralappliance 200 may comprise a mouth guard portion 220. In some aspects,the hard palate portion 230 may extend upward from the mouth guardportion 220 to a central point of convergence.

In some embodiments, the hard palate portion 230 may interface with thehard palate 260. In some aspects, the surface of the hard palate portion230 may mirror the geometry of the hard palate 260 to provide a customfit. In some embodiments, the hard palate portion 230 may compriseidentical geometry to the hard palate 260 by being cured in a moldformed from an impression of the user's oral cavity. In someimplementations, this mold may be a standard mold used in creatingdenture impressions.

In some implementations, the distal end of the therapeutic oralappliance 200 may align with the beginning of the soft palate 270 withinthe oral cavity. This may prevent damage from continual applied force onthe soft palate 270. In some implementations, the mouth guard portion220 may interface with the teeth 250. In some aspects, the interactionbetween the guard portion 220 and the teeth 250 may operate as a matedinterface that is formed by curing the resin for the therapeutic oralappliance 200 within a casting made from an impression of the user'steeth 250.

A patient may wear a therapeutic oral appliance 200 without tongueretainer portion to begin the incremental process to suppress the gagreflex. Wearing a therapeutic oral appliance 200 may be uncomfortable atfirst, particularly for those who are unaccustomed to wearing oralappliances. A patient may get used to the therapeutic oral appliance 200by wearing it for a few hours and then overnight, as a way to build upto the gag reflex suppression process with the tongue retainer portion.

In some embodiments, the mouth guard portion 220 may comprise a genericcast that, upon inducing heat to increase malleability, may be formed tothe shape of the intended teeth 250. This may provide greater comfortwhen wearing the therapeutic oral appliance 200. A formed therapeuticoral appliance 200 may prevent unconscious reject from the mouth. Forexample, a user may unconsciously spit out the therapeutic oralappliance while sleeping unless the therapeutic oral appliance 200 ishomogeneous with the structure of the oral cavity.

In some aspects, the mouth guard portion 220 may comprise a cavitydesigned to enclose a plurality of teeth 250 simultaneously. Thethickness of the outside edge of the mouth guard portion 220 may be ofminimal thickness to ensure an unobstructive fit within the oral cavity.In some embodiments, a minimal thickness may increase the comfort of thetherapeutic oral appliance 200 and the effectiveness of therapeuticutilization by avoiding subconscious rejection, as non-limitingexamples.

Referring now to FIG. 3A, an exemplary therapeutic oral appliance 300comprising a tongue retainer portion 310 is illustrated. Referring nowto FIG. 3B, an exemplary a cross-sectional view of an oral cavity withan exemplary therapeutic oral appliance 300 is illustrated. In someembodiments, the therapeutic oral appliance 300 may comprise a hardpalate portion 330. In some implementations, the therapeutic oralappliance 300 may comprise a mouth guard portion 320. In someembodiments, the hard palate portion 330 may interface with the hardpalate 360.

In some implementations, the tongue retainer portion 310 may align withthe soft palate 370. In some embodiments, the tongue retainer portion310 may comprise an upper surface, a lower surface, and a longitudinallength. In some aspects, the therapeutic oral appliance 300 may enterthe throat 380 via the tongue retainer portion 310. In someimplementations, the therapeutic oral appliance 300 may comprise atongue retainer portion 310 of a plurality of predetermined lengths.This may allow the user to gradually become accustomed to the presenceof the tongue retainer portion 310 within the throat 380. This may trainthe gag reflex to refrain from engaging the tongue retainer portion 310sufficient to allow the user to insert the therapeutic oral appliance300 daily. In some embodiments, the tongue retainer portion 310 may befixed to a distal end of the hard palate portion 330.

In some embodiments, the therapeutic oral appliance 300 may interfacewith the tongue 340. In some aspects, the tongue retainer portion 310may direct the tongue 340 through the physical presence of the tongueretainer portion 310. In some embodiments, the tongue retainer portion310 may restrain the tongue 340 sufficient to facilitate unobstructedbreathing.

For example, a person in a coma may need a clear airway to receivesufficient oxygen. In an unconscious state, the tongue 340 may otherwisereduce or impair the user's airway. In some implementations, the mouthguard portion 320 may be configured to at least partially interface withone or more teeth 350. This may prevent the therapeutic oral appliance300 from dislodgement and potential ingestion.

Referring now to FIG. 4A, an exemplary therapeutic oral appliance 400comprising a tongue retainer portion 410 is illustrated. Referring nowto FIG. 4B, an exemplary a cross-sectional view of an oral cavity withan exemplary therapeutic oral appliance 400 is illustrated. In someembodiments, the therapeutic oral appliance 400 may comprise a hardpalate portion 430. In some implementations, the therapeutic oralappliance 400 may comprise a mouth guard portion 420. In some aspects,the hard palate portion 430 may extend upward from the mouth guardportion 420 to a central point of convergence.

In some embodiments, the hard palate portion 430 may interface with thehard palate 460. In some implementations, the tongue retainer portion410 may align with the soft palate 470. In some embodiments, the tongueretainer portion 410 may comprise an upper surface, a lower surface, anda longitudinal length. In some aspects, the therapeutic oral appliance400 may enter the throat 480. In some implementations, the tongueretainer portion 410 may enter the throat incrementally to avoidtriggering a gag reflex. In some embodiments, the tongue retainerportion 410 may be fixed to a distal end of the hard palate portion 430.

A gag reflex is a contraction of the throat that occurs when an objectmakes contact with the back of the tongue 440 or throat 480. This gagreflex may be overcome through incremental introduction of the tongueretainer portion 410 into the throat 480. In some aspects, this may beintroduced by wearing a therapeutic oral appliance 400 with anincremental increase in tongue retainer portion length 410 for apredetermined time.

The length of the tongue retainer portion 410 may be sufficiently shortto prevent the grasping of the tongue retainer portion 410 by the throat480 via throat contraction caused by the gag reflex. The length of thetongue retainer portion 410 may be sufficiently short to preventirregular swallowing due to the throat exerting a downward force on thetherapeutic oral appliance 400 by grasping the end of the tongueretainer portion 410 during throat contraction.

In some embodiments, the therapeutic oral appliance 400 may interfacewith the tongue 440. In some embodiments, the tongue retainer portion410 may restrain the tongue 440 sufficiently to facilitate unobstructedbreathing. In some implementations, the mouth guard portion 420 may beconfigured to at least partially interface with one or more teeth 450.In some aspects, the mouth guard portion 420 may secure the therapeuticoral appliance 400 within the oral cavity. This may prevent ingestion ofthe therapeutic oral appliance 400.

Referring now to FIG. 5A, an exemplary therapeutic oral appliance 500comprising a tongue retainer portion 510 is illustrated. Referring nowto FIG. 5B, an exemplary a cross-sectional view of an oral cavity withan exemplary therapeutic oral appliance 500 is illustrated. In someembodiments, the therapeutic oral appliance 500 may comprise a hardpalate portion 530. In some embodiments, the hard palate portion 530 mayinterface with the hard palate 560. The interface between the hardpalate 560 and the hard palate portion 530 may provide stability thatreduces movement of the tongue retainer portion 510 within the throat580.

In some implementations, the therapeutic oral appliance 500 may comprisea mouth guard portion 520. In some implementations, the hard palateportion 530 may extend upward from the mouth guard portion 520 to acentral point of convergence. In some implementations, the mouth guardportion 520 may be configured to at least partially interface with oneor more teeth 550. In some aspects, the mouth guard portion 520 mayprovide a generic fit to the teeth 550 with limited malleableproperties. This generic tooth form may provide sufficient stability toprevent ingestion of the therapeutic oral appliance 500.

In some implementations, the tongue retainer portion 510 may align withthe soft palate 570. In some embodiments, the tongue retainer portion510 may comprise an upper surface, a lower surface, and a longitudinallength. In some aspects, the therapeutic oral appliance 500 may enterthe throat 580. In some implementations, the user may modify the lengthof the tongue retainer portion 510. In some aspects, the tongue retainerportion 510 may be shortened by severing the tongue retainer portion 510with scissors to the desired length. This may allow a user to customizethe length of the tongue retainer portion 510. Shortening the tongueretainer portion 510 may be necessary if the tongue retainer portion 510extends into the throat 580 sufficient to trigger the gag reflex. Insome embodiments, the therapeutic oral appliance 500 may interface withthe tongue 540.

Referring now to FIG. 6A, an exemplary therapeutic oral appliance 600comprising a tongue retainer portion 610 is illustrated. Referring nowto FIG. 6B, an exemplary a cross-sectional view of an oral cavity withan exemplary therapeutic oral appliance 600 is illustrated. In someembodiments, the therapeutic oral appliance 600 may comprise a hardpalate portion 630. In some implementations, the therapeutic oralappliance 600 may comprise a mouth guard portion 620. In some aspects,the hard palate portion 630 may extend upward from the mouth guardportion 620 to a central point of convergence. In some implementations,the mouth guard portion 620 may be configured to at least partiallyinterface with one or more teeth 650.

In some embodiments, the hard palate portion 630 may interface with thehard palate 660. In some implementations, the tongue retainer portion610 may align with the soft palate 670. In some embodiments, the tongueretainer portion 610 may comprise an upper surface, a lower surface, anda longitudinal length. In some aspects, the tongue retainer portion 610may be fixed to a distal end of the hard palate portion 630 and encroachinto the throat 680. In some implementations, the tongue retainerportion 610 may increase in length incrementally.

As an illustrative example, a user may, upon ordering the therapeuticoral appliance, receive a plurality of therapeutic oral appliancescomprising therapeutic oral appliances with incremental tongue retainerportions, such as described in FIGS. 2A-6A. In preparation for using thetherapeutic capabilities of the therapeutic oral appliance, the user mayuse a therapeutic oral appliance with incrementally longer tongueretainer portions until snoring is effectively prevented. A user maywear each size for a few days to a few weeks each, depending on thecomfort level of each therapeutic oral appliance. The user may use thetherapeutic oral appliance daily while sleeping to acclimate the throatto the tongue retainer portion and overcome the gag reflex.

Dependent upon individual anatomy, the user may discover that anintermediary length of the tongue retainer portion is of sufficientlength for therapeutic purposes, where the user may not benefit from anincrementally longer tongue retainer portion. In some embodiments, theuser may incrementally increase the length of the tongue retainerportion 610 until the length is sufficient to relieve obstruction butremain sufficiently comfortable for use while sleeping. In some aspects,the user may discover a need to trim the length of the tongue retainerportion 610 of the therapeutic oral appliance to achieve a desiredlength that is between the incremental tongue retainer portions. In someimplementations, the length of the tongue retainer portion 610 mayremain shorter than the distance to the epiglottis to ensure swallowingremains possible.

Referring now to FIG. 7A, an exemplary therapeutic oral appliance 700comprising a tongue retainer portion 710 is illustrated, wherein thetherapeutic oral appliance 700 is fitted for a child. Referring now toFIG. 7B, an exemplary a cross-sectional view of an oral cavity with anexemplary therapeutic oral appliance 700 is illustrated. In someembodiments, the therapeutic oral appliance 700 may comprise a hardpalate portion 730. In some implementations, the therapeutic oralappliance 700 may comprise a mouth guard portion 720. In some aspects,the hard palate portion 730 may extend upward from the mouth guardportion 720 to a central point of convergence.

In some embodiments, the hard palate portion 730 may interface with thehard palate 760. In some implementations, the tongue retainer portion710 may align with the soft palate 770. In some embodiments, the tongueretainer portion 710 may comprise an upper surface, a lower surface, anda longitudinal length. In some aspects, the therapeutic oral appliance700 may enter the throat 780. In some embodiments, the therapeutic oralappliance 700 may interface with the tongue 740. In someimplementations, the mouth guard portion 720 may be configured to atleast partially interface with one or more teeth 750.

For smaller mouths, such as with children, incremental increases intongue retainer portions 710 may be smaller to allow for a more refinedfit. Smaller size increases may allow for easier transition withincreased likelihood that the gag reflex suppression may occur withoutissue. Smaller mouths may require shorter tongue retainer portions 710.In some aspects, the incremental sizes of tongue retainer portions 710may depend on predefined factors, such as strength of gag reflex, mouthsize, user preference, practitioner recommendations, or level ofcustomization. For example, where the therapeutic oral appliance isprescribed by a practitioner, the increments may be more customized thanan over-the-counter version of a therapeutic oral appliance.

Referring now to FIGS. 8A-8B, a front view of an exemplary therapeuticoral appliance 800 is illustrated. In some embodiments, the tongueretainer portion 810 of the therapeutic oral appliance 800 may compriseone or more uniform recesses or slots that span the longitudinal lengthof the tongue retainer portion 810 to create an airway 815. In someimplementations, the airway 815 may comprise uniform indentations alongthe sidewall of the tongue retainer portion 810. In some aspects, theairway 815 may comprise air flow pathways that are parallel to thedirection of the throat.

For example, the tongue retainer portion 810 may comprise one or moreairway 815 tubes that continue for the longitudinal length of the tongueretainer portion 810. This may be useful if the throat is inflamed orotherwise restricted so as to render embedded channels within the wallsof the tongue retainer portion 810 ineffective. In some embodiments, theairway 815 may comprise an integrated tube that runs through the centerof the tongue retainer portion 810. This may reduce the requiredinsertion diameter and prevent obstruction by utilizing existingmaterial that extends the length of the therapeutic oral appliance 800.

Referring now to FIG. 9 , a mouth wearing an exemplary therapeutic oralappliance 900 is illustrated. In some embodiments, the mouth guardportion 920 may be configured to at least partially interface with oneor more teeth 950 in a form fit. The therapeutic oral appliance 900 mayfit similarly to a sport mouth guard, teeth whitening tray, incrementalbraces systems, or teeth grinding protectors, as non-limiting examples.In some aspects, a therapeutic oral appliance 900 may fit over dentures.In some embodiments, a therapeutic oral appliance 900 may fit over gumsfor user's who may remove their dentures at night.

Referring now to FIG. 10 , an exemplary therapeutic oral appliance 1000with a safety mechanism is illustrated. In some embodiments, thetherapeutic oral appliance 1000 may comprise at least one safetymechanism 1005. In some implementations, the safety mechanism 1005 mayextend the entirety of the length of the therapeutic oral appliance1000. In some aspects, this may prevent the ingestion of a portion ofthe therapeutic oral appliance 1000 that may break off from thetherapeutic oral appliance 1000. This may be possible after prolongeduse creates fatigue within the therapeutic oral appliance 1000 thatcreates structural instability within the therapeutic oral appliance1000.

Referring now to FIGS. 11A-11B, an exemplary therapeutic oral appliance1100 with a mouth guard portion 1120 attachment is illustrated. In someembodiments, the mouth guard portion 1120 may comprise at least oneexternal attachment. In some aspects, the external attachment maymaintain a partially opened state for the mouth. In someimplementations, the external attachment may be configured to interfacewith at least one supplemental device. The external attachment maycomprise at least one aperture or opening that allows for the insertionof a variety of supplemental devices in the form of tubes into the oralcavity.

As an example, an anesthesiologist may insert tubes to regulate sedationduring surgery. This opening in the external attachment, with supportfrom the hard palate portion 1130, may provide stability that allows thetube to remain in a fixed state. A source of humidified air or oxygenmay be diffused near the oral cavity to provide humidification. This mayassist in preventing dryness in the mouth and oropharynx. The reduceddryness may provide increased user comfort. As another example, afeeding tube may interface with the external attachment to providenutrition to a user in a coma. Supplemental tubes may also sustainhealth for users with a variety of health challenges.

As an illustrative example, a tube opening may provide access to theoral cavity while a user undergoes an epileptic seizure. The tongueretainer portion 1110 may assist in stabilizing the tongue andmaintaining an unobstructed airway. The tube opening may assist indampening muscular contractions within the jaw that may otherwise harmthe user during the epileptic seizure. The tube opening may alsomaintain an orifice for the duration of the episode in case vomitingoccurs.

Physical disabilities may also necessitate the utilization ofsupplemental tubes for sustenance. For example, a user with cerebralpalsy may struggle with aspiration due to muscle weakness. This maynecessitate a breathing tube. Due to other muscular atrophy and fatigue,a feeding tube may also be employed to ensure adequate nutrition. Atherapeutic oral appliance 1100 may allow for prolonged use with reducedrisk of damage to a user's mouth, throat, respiratory system, andoverall health.

Referring now to FIGS. 12A-12B, an exemplary therapeutic oral appliance1200 with a mouth guard portion 1220 attachment is illustrated. In someembodiments, the mouth guard portion 1220 may comprise at least oneexternal attachment. In some implementations, the mouth guard portion1220 may interface with at least one supplemental device 1290. In someembodiments, the mouth guard portion 1220 may interface with at leastone supplemental device 1290 via the external attachment. In someaspects, the external attachment may maintain a partially opened statefor the mouth. In some embodiments, the external attachment may comprisean aperture or opening that allows for the insertion of a variety ofsupplemental devices 1290 in the form of tubes into the oral cavity.

As an example, an anesthesiologist may insert a tube to regulatesedation during surgery. This opening in the external attachment, withsupport from the hard palate portion 1230, may provide stability thatallows the tube to remain in a fixed state. The opening in the externalattachment may comprise a similar diameter to commonly interfacedsedation tubes. A source of humidified air or oxygen may be diffusednear the oral cavity to provide humidification. This may assist inpreventing dryness in the mouth and oropharynx. The reduced dryness mayprovide increased user comfort.

Physical disabilities may also necessitate the utilization ofsupplemental tubes for sustenance. For example, a user with cerebralpalsy may struggle with aspiration due to muscle weakness. This maynecessitate a breathing tube. Due to other muscular atrophy and fatigue,a feeding tube may also be employed to ensure adequate nutrition. Atherapeutic oral appliance 1200 may allow for prolonged use with reducedrisk of damage to a user's mouth, throat, respiratory system, andoverall health.

Referring now to FIGS. 13A-13B, a side view of exemplary therapeuticoral appliance 1300 with a mouth guard portion attachment isillustrated. In some embodiments, the therapeutic oral appliance 1300may comprise a mouth guard portion 1320. In some implementations, themouth guard portion 1320 may comprise an attachment to prevent thegrinding of the teeth. In some aspects, the therapeutic oral appliance1300 may comprise a hard palate portion 1330 that may assist withreducing translational movement caused by teeth grinding. In someimplementations, the hard palate portion 1330 may extend upward from themouth guard portion 1320 to a central point of convergence.

Referring now to FIG. 14A-14B, a side view of exemplary therapeutic oralappliance 1400 with a mouth guard portion attachment is illustrated. Insome embodiments, the therapeutic oral appliance 1400 may comprise amouth guard portion 1420. In some implementations, the mouth guardportion 1420 may comprise an attachment to prevent the grinding of theteeth. In some aspects, the therapeutic oral appliance 1400 may comprisea hard palate portion 1430 that may assist with reducing translationalmovement caused by teeth grinding. In some embodiments, the hard palateportion 1430 may extend upward from the mouth guard portion 1420 to acentral point of convergence.

In some aspects, the therapeutic oral appliance 1400 may interface withthe lower jaw via attachment to a lower therapeutic oral appliance 1400.In some embodiments, a therapeutic oral appliance may cover the lowerteeth. In some implementations, the therapeutic oral appliance mayconnect to the therapeutic oral appliance 1400 secured to the upperpalate. This may increase comfort and security, as non-limitingattributes. A lower therapeutic oral appliance may decrease theprobability of the user spitting out the therapeutic oral appliance1400.

Referring now to FIGS. 15A-15B, an exemplary therapeutic oral appliance1500 with an adjustable tongue retainer portion 1510 is illustrated. Insome embodiments, the tongue retainer portion 1510 may comprise an uppersurface, a lower surface, and a longitudinal length. In some aspects,the tongue retainer portion 1510 may extend into the throat at a varietyof lengths that are determined by a plurality of predeterminedlongitudinal lengths that are adjusted in a region of the therapeuticoral appliance 1500. In some embodiments, the tongue retainer portion1510 may be fixed to a distal end of the hard palate portion 1530. Insome implementations, the tongue retainer portion 1510 may be removedfrom the therapeutic oral appliance 1500. This may be a helpful statefor users who are beginning the acclimation process of the tongueretainer portion 1510 within the throat.

In some embodiments, the adjustable aspect of the tongue retainerportion 1510 may interface with an extrusion connected to the mouthguard portion 1520. In some aspects, the adjustment of the tongueretainer portion 1510 may comprise a mechanism that exerts force on afixture attached to the therapeutic oral appliance 1500. In someimplementations, the hard palate portion 1530 may provide stability asthe therapeutic oral appliance 1500 is adjusted within the oral cavity.In some aspects, the tongue retainer portion 1510 may comprise an airway1515 that extends in conjunction with the extension of the tongueretainer portion 1510.

In some embodiments, the airway 1515 may originate on the top of themouth guard portion 1520. In some implementations, the airway 1515 andtongue retainer portion 1520 may be molded to follow the contour of thehard palate and soft palate. In some aspects, one or more channels forairway patency are included along the sides of airway 1515. In someembodiments, these channels may begin between the teeth or gums, asnon-limiting options, in the case of edentulism, to provide airwaypatency so the airway 1515 is not occluded by the teeth or lips.

In some embodiments, the airway 1515 and the tongue retainer portion1520 may comprise a reinforced bridge portion that runs along themidline, near the midline, or parallel to midline of the hard palate andsoft palate, as non-limiting alternatives. In some implementations, thisreinforced portion may be attached to a flattened section that runsparallel to the hard palate portion 1530. This may provide increasedsurface area to push and stabilize the tongue and soft palate tissueaway from each other to provide an airway 1515. In some aspects, the gapcreated by the reinforced bridge between the palate and the flattenedplane may facilitate air flow. In some embodiments, the parallel planesseparated by the reinforced bridge may form the airway 1515.

As an illustrative example, the cross section of this structural designmay be similar to an I-beam. The I-beam consists of two horizontalplanes, known as flanges, connected by one vertical component, or theweb. The shape of the flanges and the web create an “I” cross-section.The flanges correlate to the planes touching the palate on one end andthe tongue on the other end.

The web correlates to the reinforced bridge that is the verticalcomponent that connects the two horizontal planes. The space between theflanges created by the web is the channel where the air flow passes. Thecross-sectional area for the airway 1515 may be sufficient to preventincreased respiratory effort or increased negative pressure on thelungs.

Referring now to FIG. 16A-16B, an exemplary therapeutic oral appliance1600 with an adjustable tongue retainer portion 1610 is illustrated. Insome embodiments, the tongue retainer portion 1610 may comprise an uppersurface, a lower surface, and a longitudinal length. In some aspects,the tongue retainer portion 1610 may extend into the throat at a varietyof lengths that are determined by a plurality of predeterminedlongitudinal lengths that are adjusted in a region of the therapeuticoral appliance 1600. In some implementations, the tongue retainerportion 1610 may be removed from the therapeutic oral appliance 1600.

In some embodiments, the mouthguard portion 1620 may remain fixed whilethe airway 1615 may be moved and secured at different depths within thethroat. In some implementations, the airway 1615 channel may be slidback and forth until the desired depth into the throat is reached. Insome aspects, the airway 1615 may be secured into this position by aclamp or another non-limiting securing device.

For example, a client may purchase a single therapeutic oral applianceand, at first, may use the therapeutic oral appliance with an airwaythat is completely retracted. The client may gradually increase theextension of the airway into the throat until the airway has extendedthe originally intended distance into the throat.

In some embodiments, the airway 1615 may originate on the top of themouth guard portion 1620. In some implementations, the airway 1615 andtongue retainer portion 1620 may be molded to follow the contour of thehard palate and soft palate. In some aspects, one or more channels forairway patency are included along the sides of airway 1615. In someembodiments, these channels may begin between the teeth or gums, asnon-limiting options, in the case of edentulism, to provide airwaypatency so the airway 1615 is not occluded by the teeth or lips.

Referring now to FIG. 17 , an exemplary therapeutic oral appliance 1700is illustrated. In some embodiments, the mouth guard portion 1720 maycomprise a plurality of components. In some aspects, the mouth guardportion 1720 may comprise a brace with selective teeth caps. Forexample, at least one flexible wire may prevent slipping by applying aminimal retaining force upon the front teeth. A symmetrical plurality oftooth caps may be attached to the flexible wire and secure thetherapeutic oral appliance 1700 by enclosing a plurality of teeth onboth sides of the mouth.

In some embodiments, the tooth caps may comprise a generic cast that,upon inducing heat to increase malleability, may be formed to the shapeof the intended teeth. In some aspects, the tooth cap may comprise acavity designed to enclose a plurality of teeth simultaneously. Thethickness of the outside edge of the tooth cap may be of minimalthickness to ensure a fit between the teeth enclosed within the toothcap and those excluded. In some implementations, a mold may provide amated fit between the hard palate portion 1730 and the hard palatewithin the oral cavity.

Referring now to FIG. 18 , an exemplary therapeutic oral appliance 1800is illustrated. In some embodiments, the mouth guard portion 1820 maycomprise a plurality of components. In some aspects, the mouth guardportion 1820 may comprise a brace with selective teeth caps. In someembodiments, the teeth caps may enclose a plurality of teeth singularly.In some implementations, the mouth guard portion 1820 may allow a userto bite down on the therapeutic oral appliance 1800 without requiring afitting over teeth. This may allow for a more universal fit, such as forover-the-counter solutions.

For example, the teeth caps may enclose three teeth separately on bothsides of the mouth to ensure the required stability and security for thetherapeutic oral appliance 1800. In some implementations, a mold mayprovide a mated fit between the hard palate portion 1830 and the hardpalate within the oral cavity. In some aspects, the hard palate portion1830 may comprise a variety of materials to accommodate a plurality ofpreferences. As an example, the therapeutic oral appliance 1800 maycomprise silicone for ideal softness, durability, and hygiene.

In some embodiments, the therapeutic oral appliance may comprise a softsilicone material with low shore hardness. This may provide an airway1815 channel for breathing that allows for flexibility. The flexibilitymay allow the patient to swallow and maintain some tongue movement. Thisallowance may increase comfort for the patient. In some implementations,the mouth guard portion 1820 may cover one or more teeth or gums as ameans to protect teeth from pressure points from the oral airway. Themouth guard portion 1820 may stabilize the oral airway while the user isunconscious to reduce the chance of inadvertent rejection by spittingout the therapeutic oral appliance 1800.

For example, a user's hard palate may be prone to inflammation wheninterfacing with typical medical grade plastics and polymers. The usermay experience greater comfort and utility by utilizing a therapeuticoral appliance 1800 that comprises a hard palate portion 1830 composedof a metal or silicone mesh. A flexible or meshed hard palate portion1830 may allow for a snug fit without requiring a custom mold.

Referring now to FIG. 19 , an exemplary adjustable therapeutic oralappliance 1900 is illustrated. In some embodiments, the mouth guardportion 1920 may comprise a plurality of components. In someimplementations, the dimensions of the therapeutic oral appliance 1900may be adjustable. In some aspects, the tongue retainer portion 1910 mayattach to a frame of the therapeutic oral appliance 1900. In someembodiments, the hard palate portion 1930 may interface with a minimizedregion of the hard palate.

In some implementations, a mouth may be changing and growing quickly,such as with children. Their mouth size and shape may change betweenincremental tongue retainer portions 1910, which may make it impracticalto use one mouth mold to create the incremental therapeutic oralappliances 1900. In some aspects, a mouth guard portion 1920 may fitover a few teeth, such as front teeth and back molars, that are unlikelyto shift or change drastically during the acclimation period for thetherapeutic oral appliance 1900. This may be combined with an extendablehard palate portion 1930 that may allow for growth.

Referring now to FIG. 20 , an exemplary therapeutic oral appliance 2000configured to interface with one or more dental fixtures, such as bybeing attachable thereto, is illustrated. In some aspects, the dentalfixtures may be attached to the teeth 2050. For example, the therapeuticoral appliance 2000 may connect to the metal fastening rods located onbraces 2055 that are secured to the teeth 2050. For example, a teenagermay overcome sleep apnea while wearing braces by attaching thetherapeutic oral appliance 2000 to hooks on braces attached to thecanine teeth. In some embodiments, the mouth guard portion 2020 mayextend rearward into the mouth. In some implementations, the hard palateportion 2030 may interface with a minimized region of the hard palate.

Referring now to FIG. 21 , an exemplary therapeutic oral appliance 2100with wireless data transmission capabilities is illustrated. In someembodiments, the therapeutic oral appliance may contain a plurality ofelectronic components that may be configured to interface with at leastone external device 2190. In some implementations, the therapeutic oralappliance 2100 may be configured to interface with and relay informationto at least one wearable device 2195 (such as, for example and notlimitation, a smart watch). In some aspects, the tongue retainer portion2110 may comprise a one or more sensors.

In some embodiments, the airway 2115 may contain a plurality ofelectronic components. For example, the therapeutic oral appliance 2100may comprise electrodes that may provide transcutaneous electricalstimulation to oropharyngeal and tongue muscles. This may increasemuscle tone, allowing for an opening of the patient airway channel.

For example, a child prone to seizures may use a therapeutic oralappliance 2100 with an embedded accelerometer that notifies the parentsof shape increases in rapid movement that may be indicative of aseizure. This may be helpful at night when the family is asleep and theparents may otherwise remain unaware of the child's seizure. Thetherapeutic oral appliance 2100 may limit likelihood that a seizure maycause the tongue to obstruct the child's airway, which may causepermanent or temporary brain damage.

As another example, a user may purchase a therapeutic oral appliance2100 to overcome sleep apnea that pairs with an external device 2190 inthe form of the user's phone (such as, for example and not limitation, asmartphone) or computing device, such as a desktop computer, a laptopcomputer, or tablet as non-limiting examples. Embedded accelerometersand heart rate monitors may record information as the user sleeps todisplay quality of sleep information. The user may be able to see howrestless they slept as well as their rest heart rate and oxygen levels.This may assist in overcoming sleep apnea by emitting vibrationalfrequencies during sleep to reposition the user to a better sleepingposition when oxygen levels are too low.

As another example, a user may be recovering from an illness that has ahigh rate of respiratory issues. The therapeutic oral appliance 2100 maytrack oxygenation levels (for example, by using a pulse oximeter) andheart rate to monitor and manage symptoms. Where levels drop belowpredefined threshold parameters, a practitioner or hospital may benotified. If a user is unresponsive to the practitioner, an ambulancemay be sent.

As an illustrative example, an anesthesiologist may insert a therapeuticoral appliance 2100 during a surgery that comprises one or more healthmonitors. The anesthesiologist may monitor heart rate, oxygen levels,and breathing rate during the surgery. This information may display viaBluetooth connection with one or more external devices 2190 in the formof one or more medical apparatuses stationed within the operation room.The medical equipment may be configured to convey notifications andalarms for predetermined thresholds. The medical equipment may notifythe anesthesiologist of recommended times to routinely evaluate specifichealth criterion based on current health levels of the patient.

As another illustrative example, the therapeutic oral appliance 2100 maycomprise a capnograph or gas analyzer. A capnograph may measurepredefined gases, such as inhaled oxygen and expired carbon dioxide. Agas analyzer may indicate how much oxygen therapy may be required toachieve a desired blood oxygen saturation. The gas monitors may provideindicative information regarding a patient's ventilation. Audible andvisual indicators may notify the healthcare professional if there isobstruction or hypercarbic symptoms due to OSA or poor ventilation.

Referring now to FIGS. 22A-22B, a process 2200 of forming an exemplarytherapeutic oral appliance is illustrated. In some embodiments,therapeutic oral appliance may be formed from an impression. In someimplementations, the impression may comprise an impression of teeth andan impression of the hard palate, as non-limiting options. For example,physical impressions may be made of the upper hard palate, dentition,and as much of the soft palate as can be tolerated.

In some aspects, the impressions of the patient's mouth may be rendereddigitally. As an example, an impression may be scanned by ahigh-fidelity 3-D scanner to render a virtual representation of theimpression within a modeling software. In some embodiments, a digitalrendering of an airway may be created along the longitudinal length ofthe digital impression of the therapeutic oral appliance. In someimplementations, a physical construction of the digital rendering andairway may be formed. For example, the digital rendering may be printedby a 3-D printer. In some embodiments, this physical construction mayprovide a tangible medium to further the formation of the therapeuticoral appliance, such as by providing a shape for a mold.

In some aspects, a mold may be formed using the physical rendition ofthe impression and the airway. In some embodiments, the mold may be usedto create a therapeutic oral appliance by using the mold for casting.For example, a 3-D printed prototype may be place in casting clay toform an impression that is subsequently filled with a soft siliconematerial. As another example, a synthetic polymer may be poured into themold and, upon solidifying, may produce a therapeutic oral appliance inthe form of the impression and the airway.

Referring now to FIG. 23 , a method 2300 of forming an exemplarytherapeutic oral appliance is illustrated. At 2305, physical impressionsof a patient's mouth may be formed. In some embodiments, the impressionsmay comprise an impression of the teeth and an impression of the hardpalate, as non-limiting options. At 2310, the impressions of thepatient's mouth may be scanned in three dimensions. As an example, animpression may be scanned by a high-fidelity 3-D scanner to render avirtual representation of the impression within a modeling software.

At 2315, a digital rendering of an airway may be created along thelongitudinal length of the digital impression. At 2320, a physicalconstruction of the digital impression and airway may be constructed.For example, the digital rendering of the impression and the airway maybe printed by a 3-D printer.

At 2325, a mold may be formed using the physical rendition of theimpression and the airway. At 2330, the mold may be used to create atherapeutic oral appliance by using the mold for casting. For example, asynthetic polymer may be poured into the mold and, upon solidifying, mayproduce a therapeutic oral appliance in the form of the impression andthe airway.

CONCLUSION

A number of embodiments of the present disclosure have been described.While this specification contains many specific implementation details,these should not be construed as limitations on the scope of anydisclosures or of what may be claimed, but rather as descriptions offeatures specific to particular embodiments of the present disclosure.

Certain features that are described in this specification in the contextof separate embodiments can also be implemented in combination or in asingle embodiment. Conversely, various features that are described inthe context of a single embodiment can also be implemented incombination in multiple embodiments separately or in any suitablesub-combination. Moreover, although features may be described above asacting in certain combinations and even initially claimed as such, oneor more features from a claimed combination can in some cases be excisedfrom the combination, and the claimed combination may be directed to asub-combination or variation of a sub-combination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. In certain circumstances, multitasking and parallel processingmay be advantageous.

Moreover, the separation of various system components in the embodimentsdescribed above should not be understood as requiring such separation inall embodiments, and it should be understood that the described programcomponents and systems can generally be integrated together in a singlesoftware product or packaged into multiple software products.

Thus, particular embodiments of the subject matter have been described.Other embodiments are within the scope of the following claims. In somecases, the actions recited in the claims can be performed in a differentorder and still achieve desirable results. In addition, the processesdepicted in the accompanying figures do not necessarily require theparticular order show, or sequential order, to achieve desirableresults. In certain implementations, multitasking and parallelprocessing may be advantageous. Nevertheless, it will be understood thatvarious modifications may be made without departing from the spirit andscope of the claimed disclosure.

What is claimed is:
 1. A therapeutic oral appliance comprising: a mouthguard portion, wherein the mouth guard portion is configured to at leastpartially interface with one or more teeth of a user; a hard palateportion configured to at least partially interface with a hard palate ofa mouth of the user, wherein the hard palate portion extends upward fromthe mouth guard portion; a tongue retainer portion, wherein the tongueretainer portion extends from the hard palate portion into at least aportion of a throat of the user, wherein the tongue retainer portioncomprises an upper surface, a lower surface, two opposing sidewalls, anda longitudinal length; and at least one airway, wherein the at least oneairway comprises one or more indentations within each of the twosidewalls of the tongue retainer portion, wherein the at least oneairway extends along at least a portion of the longitudinal length ofthe tongue retainer portion, wherein the at least one airway comprisesan air flow pathway that follows a natural anatomical airway passage ofthe user.
 2. The therapeutic oral appliance of claim 1, wherein themouth guard portion comprises at least one safety mechanism.
 3. Thetherapeutic oral appliance of claim 1, wherein the tongue retainerportion is fixed to a distal end of the hard palate portion.
 4. Thetherapeutic oral appliance of claim 1, wherein the longitudinal lengthof the tongue retainer portion is adjustable.
 5. The therapeutic oralappliance of claim 1, wherein the mouth guard portion comprises at leastone external attachment configured to interface with at least onesupplemental device.
 6. The therapeutic oral appliance of claim 5,wherein the at least one external attachment comprises at least oneaperture.
 7. The therapeutic oral appliance of claim 6, wherein the atleast one supplemental device comprises a tube.
 8. The therapeutic oralappliance of claim 1, wherein the mouth guard portion comprises auniversal fit that may be used by a generic user.
 9. The therapeuticoral appliance of claim 1, wherein the mouth guard portion is configuredto interface with one or more dental fixtures.
 10. The therapeutic oralappliance of claim 9, wherein the one or more dental fixtures comprisebraces.
 11. The therapeutic oral appliance of claim 1, wherein the mouthguard portion comprises at least one wire.
 12. The therapeutic oralappliance of claim 1, wherein the mouth guard portion comprises an atleast partially customized fit for a specific user.
 13. The therapeuticoral appliance of claim 1, wherein the mouth guard portion isadjustable.
 14. The therapeutic oral appliance of claim 1, wherein thehard palate portion extends upward from the mouth guard portion to apoint of central convergence.
 15. The therapeutic oral appliance ofclaim 1, wherein the tongue retainer portion extends directly from thehard palate portion into the at least a portion of the throat of theuser.
 16. The therapeutic oral appliance of claim 1, wherein a crosssection of the tongue retainer portion substantially comprises an I-beamstructure.
 17. The therapeutic oral appliance of claim 1, wherein thetherapeutic oral appliance at least partially comprises at least onesilicone material.
 18. The therapeutic oral appliance of claim 1,wherein the therapeutic oral appliance at least partially comprises atleast one material that comprises a low shore hardness.
 19. Thetherapeutic oral appliance of claim 1, wherein the therapeutic oralappliance comprises at least one material that becomes pliable whenexposed to heat.
 20. The therapeutic oral appliance of claim 1, whereinthe at least one airway originates and extends from a top portion of themouth guard portion.